MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-09 for BBL * 221734 manufactured by Bd.
[18069407]
The laboratory has received approximately 110 cdc anaerobe 5% sheep blood agar prepared plated media that were contaminated with listeria monocytogenes. Most of the plates have only one colony but some plates have several colonies. The colonies can be seen on the contaminated plates through the sealed packages straight out of the box with no incubation involved. ====================== manufacturer response for prepared plated media: cdc anaerobe 5% sheep blood agar, bbl cdc anaerobe 5% sheep blood agar (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3816571 |
| MDR Report Key | 3816571 |
| Date Received | 2014-05-09 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-05-08 |
| Report Date | 2014-05-09 |
| Date Reported to FDA | 2014-05-09 |
| Date Reported to Mfgr | 2014-05-19 |
| Date Added to Maude | 2014-05-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL |
| Generic Name | CULTURE MEDIA, SELECTIVE |
| Product Code | JSG |
| Date Received | 2014-05-09 |
| Model Number | * |
| Catalog Number | 221734 |
| Lot Number | 4077423 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 5859 FARINON DR STE 200 SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-09 |